Good Clinical Practices Question and Answer Guide 2003

- $39.95

Developed with input from over 100 industry and government clinical trial and GCP experts, this new reference guide answers almost 400 of the most common and difficult questions regarding the day-to-day interpretation and implementation of GCP requirements for drug, biologics, and device trials. In one pocket handbook, you'll have the authoritative answers to hundreds of common and emerging questions, in 20 GCP-related areas, right at your fingertips:

FDA and ICH GCP Standards for Clinical Research

Form FDA 1572-Statement of Investigator

Informed Consent

Source Data/Documentatio

Investigator/Site Requirements

Clinical Monitoring

Clinical Study Safety Reporting

HIPA

Clinical Trial Protocols/Protocol Changes/Protocol Violations

Institutional Review Boards

Quality Assurance Activities/Study Auditing/FDA Inspections

Investigational Drug Accountability, Administration, and Labeling

Also provides all FDA, ICH, and EU GCP-related regulations and guidances in one source!